The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Play Massage Gel Lubricant.
| Device ID | K063385 |
| 510k Number | K063385 |
| Device Name: | DUREX PLAY MASSAGE GEL LUBRICANT |
| Classification | Lubricant, Personal |
| Applicant | SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Contact | Chris Robinson |
| Correspondent | Chris Robinson SSL AMERICAS, INC. 3585 ENGINEERING DR. SUITE 200 Norcross, GA 30092 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2008-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20302340876395 | K063385 | 000 |
| 10302340876381 | K063385 | 000 |
| 10302340876374 | K063385 | 000 |
| 20067981963025 | K063385 | 000 |
| 10067981087748 | K063385 | 000 |
| 20067981963032 | K063385 | 000 |
| 00067981963038 | K063385 | 000 |
| 00067981087741 | K063385 | 000 |